Recall Z-0852-2016 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Stryker Spine
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion handle at two di
| Date | Dec 16, 2015 |
| Status | Terminated |
| Reason | There were two potential interference conditions identified with the way the tubing set attaches to the inserter. |
| Root cause | Device Design |
| Action | Stryker Spine sent an Urgent Product Removal letter dated December 17, 2015 to affected customers via Fed Ex priority overnight. The letter identified the affected product, problem and actions to be taken. Customers are asked to follow instructions included in the letter. The customer response form should be completed and sent back to email via Spine-RegulatoryActions@Stryker.com or Fax 855-632-9049. For questions call (201)749-8389. |
| Quantity | 413 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143616 | AccuLIF TL and PL Cage Stryker Corporation, Mar 5, 2015 |